FDA.report

IHC

Primary DI
00810170551925
Brand
IHC
Company
Slmp, LLC
Model
(BTO) Antibody PRAME Conc Rabbit Monoclonal 0.5mL
Catalog number
RM60-05
Device description
RM55-05: PRAME, Clone EPR20330, .5mL Concentrate
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810170551925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170551925008101705519258101705519250810170551925

GMDN Terms

TermDefinition
Preferentially expressed antigen in melanoma (PRAME) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of preferentially expressed antigen in melanoma (PRAME) protein in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118544521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810170552328IHC(BTO) Manual Melanoma (HMB45) Antibody (2ml)SAM-MM100-22025-03-14
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00810170552977IHC(BTO) Sample Cytokeratin AE1 Acidic (AE1) AntibodySAM-MM49-22025-03-14
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00810170552991IHC(BTO) Sample Cytokeratin CAM 5.2 Antibody (2ml)SAM-MM51-22025-03-14

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